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Kids In Control OF Food (KICk-OFF)

A multicentre, randomised controlled trial comparing intensive structured education with standard education in 11 - 16 year olds on intensive insulin therapy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN37042683
Enrollment
576
Registered
2010-07-07
Start date
2008-09-01
Completion date
Unknown
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Diabetes Research Network, Medicines for Children Research Network

Interventions

Intervention: 5 day, outpatient, skills training course, designed and piloted specifically for this age group Control: Standard care Treatment and follow-up duration:

Sponsors

Sheffield Children's NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. T1DM of at least 1 year's duration 2. Already on or willing to use multiple dose insulin (MDI) 3. Aged 11 - 16 years (in Secondary School years 7 - 12), either sex

Exclusion criteria

Exclusion criteria: 1. Factors which will impair group participation 2. Non-English speaking 3. Learning disability - additional help in school 4. Major behavioural problems 5. Evidence of an eating disorder 6. Associated illness that may influence control

Design outcomes

Primary

MeasureTime frame
Change in HbA1c %, measured at baseline, 6 months, 12 months and 24 months

Secondary

MeasureTime frame
Measured at baseline, 6 months, 12 months and 24 months: 1. Change in psychological outcome in parents and children 2. Changes in weight, height and body mass index (BMI) 3. Diet related behaviours 4. Health economic analysis 5. Health economic modelling of long term cost/benefits 6. Change in the number and severity of hypoglycaemic episodes

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026